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Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
Date:9/25/2007

BARCELONA, Spain, Sept. 25 /PRNewswire/ -- Five-year follow-up overall survival data from the X-ACT (Xeloda in Adjuvant Colon Cancer Trial) study show that oral chemotherapy Xeloda(R) (capecitabine) is as effective as the current standard treatment - intravenous bolus 5-FU/LV (5-fluorouracil/ leucovorin) - in the adjuvant treatment of Dukes' C colon cancer. These data were presented today at the 14th European Cancer Conference (ECCO) in Barcelona, Spain.

Results show five-year overall survival rates for Xeloda at 71.4 percent compared to 68.4 percent in the 5-FU/LV arm. Additional data presented at the meeting from a previous analysis show that Xeloda is also comparable to 5- FU/LV with respect to disease-free survival (DFS) and relapse-free survival (RFS).

"These updated five-year overall survival data provide further proof that Xeloda can be a safe and effective alternative to the current standard of care for adjuvant colorectal cancer, which can require upwards of 30 clinic visits over the 24-week treatment course," said Dr. Howard Burris of the Sarah Cannon Research Institute, Nashville, Tenn., and lead U.S. investigator in the study. "Based on this evidence, physicians - especially those who have relied on 5- FU/LV - should feel confident about exploring Xeloda as a treatment option with their patients who could benefit from the flexibility of oral chemotherapy."

Previous results from the X-ACT study also show that Xeloda is more cost- effective than the Mayo Clinic regimen (the current standard treatment) and is associated with fewer side effects. Additionally, many of the side effects can be easily managed by altering the dose without compromising efficacy.(1,2) In the same analysis, costs for medicines to treat side effects, such as nausea and diarrhea, were cut by nearly 75 percent in the Xeloda arm compared to use of intravenous 5-FU/LV.

"We are pleased to see that Xeloda is standing up to its initial promise as an alternative to 5-FU/LV," said Lars Birgerson, Vice President, Medical Affairs, Roche. "Roche is committed to providing colon cancer patients with the safest and most effective treatment options that allow patients to continue their active lifestyles."

Colorectal cancer is the third most common cancer in the United States. The American Cancer Society estimates that in 2007 more than 153,500 people in the U.S. will be diagnosed and about 52,000 people will die from the disease, accounting for almost 10 percent of all cancer deaths. When colorectal cancer is detected at an early, localized stage, the five-year survival is 90 percent; however, only 39 percent of colorectal cancers are diagnosed at this stage, mostly due to low rates of screening.

About the X-ACT Trial

The international, Phase III X-ACT trial enrolled 1,987 patients (1,004 patients were randomly assigned to Xeloda; 983 patients were assigned to intravenous 5-FU/LV) who were treated for a period of 24 weeks between 1998 and 2001 at 164 centers worldwide. The primary study objective was to show equivalence in disease-free survival between Xeloda and intravenous 5-FU/LV. Secondary objectives included: relapse-free survival, overall survival and safety.

Xeloda three-year disease-free survival and relapse-free survival rates demonstrated non-inferiority to 5-FU/LV (intent-to-treat analysis, P < 0.0001; P=0.0407, respectively). Xeloda was associated with fewer adverse events than 5-FU/LV (P < 0.001).

With a median follow-up of 7 years, updated study results presented at ECCO show five-year overall survival rates for Xeloda at 71.4 percent compared to 68.4 percent in the 5-FU/LV arm.

About Xeloda

Xeloda is the only FDA-approved oral chemotherapy for both metastatic breast cancer and adjuvant and metastatic colorectal cancer. Inactive in pill form, Xeloda is enzymatically activated within the body; when it comes into contact with a naturally occurring protein called thymidine phosphorylase, or TP, Xeloda is transformed into 5-FU, a cytotoxic (cell-killing) drug. Because many cancers have higher levels of TP than does normal tissue, more 5-FU is delivered to the tumor than to other tissue.

Conventional, approved Xeloda dosing on a 14-on/7-off schedule is 1250 mg/m(2) twice daily (total of 2500 mg/m(2)/day).

A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda.

For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended. Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required.

The most common adverse events (greater than or equal to 20%) of Xeloda monotherapy were diarrhea, nausea, stomatitis and hand-foot syndrome. As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption.

About Roche

Hoffmann-La Roche Inc. (Roche), based in Nutley, N.J., is the U.S. pharmaceuticals headquarters of the Roche Group, one of the world's leading research-oriented healthcare groups with core businesses in pharmaceuticals and diagnostics. For more than 100 years in the U.S., Roche has been committed to developing innovative products and services that address prevention, diagnosis and treatment of diseases, thus enhancing people's health and quality of life. An employer of choice, in 2006, Roche was named one of the Top 20 Employers (Science magazine), ranked the No. 1 Company to Sell For (Selling Power), and one of AARP's Top Companies for Older Workers, and in 2005, Roche was named one of Fortune magazine's Best Companies to Work For in America. For additional information about the U.S. pharmaceuticals business, visit our Web sites: http://www.rocheusa.com or http://www.roche.us.

(1) Cassidy J, et al. Annals of Oncology 2002; 13: 566-575

(2) Blum J, et al. Cancer 2001; 92(7): 1759-1768


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